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Gemcitabine and Docetaxel Therapy in High-risk BCG-naive Patients With Non-muscle Invasive Bladder Cancer

Sponsor
Clinical Hospital Centre Zagreb (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05671900
Collaborator
(none)
70
Enrollment
1
Location
1
Arm
52
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Bacillus Calmette-Guerin (BCG) is the standard of care for high-risk patients with non-muscle invasive bladder cancer (NMIBC) after transurethral tumor resection. Since 2012, global BCG shortage encouraged the search of alternative treatment for NMIBC treatment. Intravesical gemcitabine and docetaxel chemotherapy (GEM/DOCE) has shown safety and efficacy in 2 retrospective, single institution cohorts. At our institution, GEM/DOCE has been offered as an option for NMIBC in the treatment of high-risk BCG-naive patients per the protocol adapted from University of Iowa, in shortage situation. Our objective is to evaluate the efficacy of GEM/DOCE therapy.

Condition or Disease Intervention/Treatment Phase
  • Drug: Gemcitabine 1000 mg, Docetaxel 37.5g
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Efficacy of Sequential Intravesical Gemcitabine and Docetaxel Therapy (GEM/DOCE) in High-risk BCG-naive Patients With Non-muscle Invasive Bladder Cancer (NMIBC)
Actual Study Start Date :
Apr 1, 2020
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: All patients

All patients receive same intervention throughout the trial.

Drug: Gemcitabine 1000 mg, Docetaxel 37.5g
6 weekly instillations of gemcitabine (1 gram of gemcitabine in 50 ml of sterile water) followed immediately by docetaxel (37.5 mg of docetaxel in 50 mL of saline) and subsequent monthly maintenance installations for those with no evidence of disease.
Other Names:
  • Sequential intravesical chemotherapy GEM/DOCE

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Reccurence free survival [2 years]

      Patients with no bladder cancer reccurence during therapy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • BCG-naive patients with high-risk non-muscle invasive bladder cancer
    Exclusion Criteria:
    • patients in whome cystectomy is planned

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Centre Zagreb Zagreb Croatia 10000

    Sponsors and Collaborators

    • Clinical Hospital Centre Zagreb

    Investigators

    • Principal Investigator: Mirko Bakula, UHC Zagreb

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mirko Bakula, PhD, Urologist, Clinical Hospital Centre Zagreb
    ClinicalTrials.gov Identifier:
    NCT05671900
    Other Study ID Numbers:
    • 81505203284
    First Posted:
    Jan 5, 2023
    Last Update Posted:
    Jan 25, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Urinary Bladder Neoplasms
    Gemcitabine
    Docetaxel

    Study Results

    No Results Posted as of Jan 25, 2023